The Medicines and Healthcare products Regulatory Agency has approved zapomeran (Kostaive) mRNA COVID‑19 vaccine for immunisation of adults aged 18 and over on 2 January 2026. The regulator said the authorisation provides an additional vaccine option for adults to prevent COVID‑19 caused by SARS‑CoV‑2.
Zapomeran is administered as a single 0.5 mL booster dose injected into the upper arm. It contains a self‑amplifying messenger RNA that instructs cells to temporarily produce the SARS‑CoV‑2 spike protein, prompting an immune response to future exposure.
Approval was granted under the International Recognition Procedure, with the European Medicines Agency acting as the reference regulator (EMA code EMEA/H/C/006207/0000).
Under the International Recognition Procedure, MHRA may take account of assessments by specified reference regulators while retaining the final UK decision. The pathway offers two timetables-Recognition A (60 days) and Recognition B (110 days)-intended to shorten authorisation compared with national review alone.
Very common reactions (affecting more than 1 in 10 people) include pain or tenderness at the injection site, tiredness, chills, fever, muscle and joint pain, headache and dizziness. These effects are usually mild and resolve within a few days.
Post‑authorisation safety monitoring remains in place. Suspected side effects should be discussed with a healthcare professional and reported to the MHRA Yellow Card scheme via yellowcard.mhra.gov.uk or the MHRA Yellow Card apps.
Formal product information will follow shortly. The Summary of Product Characteristics and the Patient Information Leaflet are due to be published on the MHRA Products website within seven days of approval (expected by 9 January 2026). Clinicians should consult these documents for final dosing, contraindications and handling instructions.
Today’s authorisation confirms that the product meets MHRA standards on quality, safety and effectiveness; it does not, by itself, determine eligibility, scheduling or procurement decisions for vaccination services. The MHRA’s role is to regulate medicines and medical devices in the UK.
Operationally, providers may wish to prepare patient communications explaining the self‑amplifying mRNA platform in clear terms, reinforce expected short‑lived reactions, and ensure Yellow Card reporting details are visible in clinics. Local teams can plan to incorporate the SmPC and PIL as soon as they are published.